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This is a safety study of human spinal cord-derived neural stem cell (HSSC) transplantation for the treatment of chronic spinal cord injury.

Condition or disease

Intervention/treatment

Phase

Spinal Cord Injury (SCI)

Drug: Human spinal cord stem cells.

Phase 1

Detailed Description:

Phase I, open-label, single-site, safety study of HSSC transplantation for the treatment of chronic spinal cord injury (SCI). Group A enrolled 4 subjects with a cord injury at T2-T12; Group B will enroll 4 subjects with a C5-C7 cord injury. Study period will be 6 months post-operative. Post-study, subjects will be followed for an additional 54 months.

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Layout table for eligibility information

Ages Eligible for Study:

18 Years to 65 Years (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Lives within 500 miles of study center (For Group B)

Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling] and comply with the study procedures

Men and women 18-65 years old

Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy or oophorectomy or surgical sterilization)

At least 1 year but no more than 2 years from time of injury at the time of surgery

SCI injury classified as AIS-A complete as confirmed by the PI and a Physical Medicine and Rehabilitation doctor or other SCI Medicine board certified physician based on a complete ISNC SCI examination

Neurologic level of injury:

Group A: injury within cord segments T2-T12;

Group B: injury within cord segments C5-C7

Confirmation of bone fusion by CT scan

Agrees to the visit schedule as outlined in the informed consent

All required vaccinations current at the time of enrollment: tetanus/diptheria (TDAP), herpes zoster/shingles (Zostavax®: within last 10 years and must be prior to surgery), pneumonia (Pneumovax®), seasonal/H1N1 flu vaccines (as appropriate for season). Any missing vaccination will be provided at the screening if consented by the otherwise eligible patient who will then be scheduled for surgery no less than 30 days post vaccination.

Exclusion Criteria:

SCI due to penetrating trauma such as gun shot or stabbing wound

SCI injuries involving complete spinal cord transection

Etiology of paraplegia or weakness related to other or additional neurologic process

MRI evidence of syrinx, multiple cysts, or a cyst with greater than 2cm in length or injury site involving greater than 2cm of the cord

Current or peak Panel Reactive Antibody (PRA) due to alloantibodies > 20% receiving their first allograft or presence of antibodies against HLA of the donor cells

Receipt of any investigational drug or device within 30 days prior to surgery